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TRUVADA + Raltegravir
This combination blocks HIV replication by inhibiting reverse transcriptase (TRUVADA) and integrase (raltegravir), preventing the virus from copying itself and integrating into host DNA.
This combination blocks HIV replication by inhibiting reverse transcriptase (TRUVADA) and integrase (raltegravir), preventing the virus from copying itself and integrating into host DNA. Used for HIV-1 infection treatment, HIV-1 pre-exposure prophylaxis (PrEP) when combined with raltegravir.
At a glance
| Generic name | TRUVADA + Raltegravir |
|---|---|
| Also known as | tenofovir DF, emtricitabine |
| Sponsor | Fenway Community Health |
| Drug class | Antiretroviral combination therapy (NRTI + INSTI) |
| Target | HIV reverse transcriptase and HIV integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
TRUVADA is a fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, both nucleoside reverse transcriptase inhibitors that block the enzyme HIV uses to convert its RNA genome into DNA. Raltegravir is an integrase strand transfer inhibitor that prevents the viral DNA from integrating into the host cell's chromosome. Together, they provide dual mechanisms to suppress viral replication.
Approved indications
- HIV-1 infection treatment
- HIV-1 pre-exposure prophylaxis (PrEP) when combined with raltegravir
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Renal impairment (with tenofovir)
- Bone density loss
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
- Post-Exposure Prophylaxis in Health Care Workers (PHASE4)
- Research on the Psychological Status of Patients With HIV-1 Infection
- Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen (PHASE2, PHASE3)
- A Study of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Evaluated as a Fixed Dose Combination Regimen in Participants Switching From an Integrase Inhibitor Who Have Experienced Rapid Weight Gain (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TRUVADA + Raltegravir CI brief — competitive landscape report
- TRUVADA + Raltegravir updates RSS · CI watch RSS
- Fenway Community Health portfolio CI